Vaccines: The Week in Review

12 July 2010
Center for Vaccine Ethics & Policy
http://centerforvaccineethicsandpolicy.wordpress.com/
A program of
- Center for Bioethics, University of Pennsylvania
http://www.bioethics.upenn.edu/
- The Wistar Institute Vaccine Center
http://www.wistar.org/vaccinecenter/default.html
- Children’s Hospital of Philadelphia, Vaccine Education Center
http://www.chop.edu/consumer/jsp/microsite/microsite.jsp

This weekly summary targets news and events in the global vaccines field gathered
from key governmental, NGO and company announcements, key journals and
events. This summary provides support for ongoing initiatives of the Center for
Vaccine Ethics & Policy, and is not intended to be exhaustive in its coverage.
Vaccines: The Week in Review is now also posted in a blog format at
http://centerforvaccineethicsandpolicy.wordpress.com/. Each item is treated as an individual
post on the blog, allowing for more effective retrospective searching. Given email
system conventions and formats, you may find this alternative more effective. This
blog also allows for RSS feeds, etc.
Comments and suggestions should be directed to
David R. Curry, MS
Editor and
Executive Director
Center for Vaccine Ethics & Policy
david.r.curry@centerforvaccineethicsandpolicy.org

NIAID (National Institute of Allergy and Infectious Diseases), part

of the National Institutes of Health, announced approximately US$14
million in first-year funding to establish 10 International Centers of
Excellence for Malaria Research (ICEMRs). NIAID said the seven-year
awards will establish the Centers in regions where malaria is endemic,
including parts of Africa, Asia, the Pacific Islands and Latin America. Teams of
scientists involved in the ICEMR program will be conducting research in more
than 20 countries. Lee Hall, M.D., Ph.D., chief of the Parasitology and
International Programs Branch in NIAID, commented that sustainable and
effective malaria control requires research in multiple settings on the
complex interactions among the parasite, the mosquito vector, the local
ecology and the human host. Dr. Hall added that "The ICEMR program seeks
to address this need by creating a network of multidisciplinary research
centers in malaria-endemic settings. The centers aim to generate critical
knowledge, tools and evidence-based strategies to support intervention and
control programs by government organizations and health care institutions."
Each center will:
- Design and conduct multidisciplinary research on the epidemiology,
transmission and pathogenesis of malaria in endemic geographic regions;
- Design and conduct special projects to capitalize on new opportunities and
emerging public health needs; and
- Develop and conduct training and career development programs for
researchers from malaria-endemic areas.
The principal investigators selected to establish the ICEMRs are as follows:
- Malaria Transmission and the Impact of Control Efforts in Southern Africa
Principal Investigator: Peter Agre, M.D.
Lead Institution: Johns Hopkins University, Baltimore
- Center for the Study of Complex Malaria in India
Principal Investigator: Jane Carlton, Ph. D.
Lead Institution: New York University School of Medicine, New York City
- Southeast Asia Malaria Research Center
Principal Investigator: Liwang Cui, Ph.D.
Lead Institution: Pennsylvania State University, University Park
- Program for Resistance, Immunology, Surveillance & Modeling of Malaria in
Uganda
Principal Investigator: Matthew Dorsey, M.D.
Lead Institution: University of California, San Francisco
- Latin American Center for Malaria Research and Control
Principal Investigator: Socrates Herrera-Valencia, M.D.
Lead Institution: Caucaseo Scientific Research Center, Cali, Colombia
- Research to Control and Eliminate Malaria in SE Asia and SW Pacific
Principal Investigator: James Kazura, M.D.
Lead Institution: Case Western Reserve University, Cleveland
- Population-based Approach to Malaria Research and Control in West Africa
Principal Investigator: Donald Krogstad, M.D.
Lead Institution: Tulane University, New Orleans
- Malaria Evolution in South Asia
Principal Investigator: Pradipsinh Rathod, Ph. D.
Lead Institution: University of Washington, Seattle
- Determinants of Malaria Disease in Malawi
Principal Investigator: Terrie Taylor, D.O.
Lead Institution: Michigan State University, East Lansing
- Peruvian/Brazilian Amazon Center of Excellence in Malaria
Principal Investigator: Joseph Vinetz, M.D.
Lead Institution: University of California, San Diego
http://www.nih.gov/news/health/jul2010/niaid-08a.htm

The WHO released this update on the Measles Initiative [full text]:
Measles Initiative highlights the importance of adherence to global
goals and strategies
In light of recent reports in the media concerning measles outbreaks, the
Measles Initiative clarifies global goals and underlines the importance of full
implementation of the recommended control strategies.
No target date has been established for achieving the global eradication of
measles. Member States attending the World Health Assembly in 2010
endorsed the following global measles control targets for 2015 as milestones
towards the eventual eradication of measles:
- to exceed 90% coverage with the first dose of measles-containing vaccine
nationally and exceed 80% vaccination coverage in every district or
equivalent administrative unit;
- to reduce annual reported measles incidence to less than five cases per
million and maintain that level; and
- to reduce measles mortality by 95% or more in comparison with 2000
estimates.
The strategies for achieving these goals are: achieving and maintaining
high population immunity through delivery of two doses of measles vaccine
to all children; effective laboratory-backed disease surveillance; and effective
treatment of measles cases including administration of vitamin A.
Consistent implementation of these strategies has resulted in substantial
progress in reducing deaths from measles — by 78%, from an estimated 733
000 deaths in 2000 to an estimated 164 000 deaths in 2008. In 2008, global
routine coverage with the first dose of measles-containing vaccine reached
83%, an increase from 72% in 2000. In 2008, more than 110 million children
received measles vaccine through mass immunization campaigns in the 47
priority countries identified as having a high measles
mortality burden in 2000. The reduction of measles deaths worldwide is
advancing progress on Millennium Development Goal 4 — to reduce child
mortality.
However, significant challenges to further progress remain. These include:
competing public health priorities; weak immunization systems; sustaining
high routine vaccination coverage; addressing the funding gap of almost US$
300 million for the 47 priority countries if the 2015 goals are to be met;
vaccinating hard-to-reach populations; and addressing an increasing number
of measles outbreaks.
In the past 12 months (from July 2009 to June 2010), measles outbreaks
have occurred in over 30 African countries, resulting in more than 89 000
reported measles cases and nearly 1400 reported measles deaths. The
majority of measles cases in these
outbreaks have occurred among children who have never been vaccinated,
indicating that lack of vaccination is the underlying cause. The recent
outbreaks serve as a stark reminder of the risks of not achieving very high
vaccination coverage (>95%)
through routine services and mass immunization campaigns. Commitment by
countries with a high burden of measles and all partners working on measles
activities to agreed goals and strategies will be the cornerstone of all efforts.
http://measlesinitiative.org/Measles/News%20Releases%20&
%20Statements/2010/MI_Statement%20in%20Response%20to%20Guardian
%20Article_July%202,%202010.pdf
Related links: Measles Initiative http://www.measlesinitiative.org/

The WER for 9 July 2010, vol. 85, 28 (pp 273–280) includes: Progress
towards eradicating poliomyelitis in Nigeria, January 2009–June 2010
http://www.who.int/wer/2010/wer8528.pdf

The WHO continues to issue weekly updates and occasional briefing notes
on the H1N1 pandemic at
http://www.who.int/csr/disease/swineflu/en/index.html
Pandemic (H1N1) 2009 - update 108
Weekly update
9 July 2010
As of 4 July, worldwide more than 214 countries and overseas territories or
communities have reported laboratory confirmed cases of pandemic
influenza H1N1 2009, including over 18311 deaths…
Situation update:
Worldwide, overall pandemic influenza activity remains low. Active circulation
of pandemic influenza virus persists in areas of the tropics, particularly in
South and Southeast Asia, the Caribbean and West Africa. Overall pandemic
and seasonal influenza activity has remained low during the early part of the
current winter season in the temperate zone of the southern hemisphere.
Low levels of seasonal influenza (H3N2 and type B) viruses were detected
during June 2010 in South Africa, while Chile, Australia, and New Zealand,
have all recently detected low levels of predominantly pandemic influenza
virus. Increasing seasonal influenza activity has also recently been observed
in several countries of Central America….
More at:http://www.who.int/csr/don/2010_07_09/en/index.html

The Global Health Council Board of Directors elected PATH

president and CEO Dr. Christopher Elias to a three-year term. The
Global Health Council describes itself as the world’s largest membership
alliance of public health organizations and professionals dedicated to saving
lives by improving health throughout the world. Dr. Elias joins new members
Elizabeth Furst Frank, senior vice president for Global Program Operations at
AmeriCares, and Patricia McGrath, a commercial real estate investor, asset
manager, and consultant. Joel Lamstein, co-founder and president of John
Snow Inc., was appointed chair of the board, succeeding Susan Dentzer,
editor-in-chief of Health Affairs.
http://www.path.org/news/an100707-ghc-board.php

The International AIDS Vaccine Initiative (IAVI) announced the

appointment of Margaret McGlynn, former President of Global
Vaccines and Anti-infectives at Merck, to its board of directors. IAVI
said Ms. McGlynn “joins a highly independent group of 16 advisors from 10
countries who meet three times a year to assess IAVI’s progress and shape
its long-term strategy.” IAVI President and CEO Seth Berkley said, “We are
delighted to have Margie on the board. We expect that her business acumen,
her hands-on experience in the vaccine industry and HIV marketplace, and
the depth of her knowledge about health, public policy and development
issues will prove invaluable to the board. She also brings considerable insight
on building strong relationships between the nonprofit and private sectors in
global health initiatives.”
http://www.businesswire.com/portal/site/home/permalink/?
ndmViewId=news_view&newsId=20100706005057&newsLang=en
Journal Watch
[Editor’s Note]
Vaccines: The Week in Review continues its weekly scanning of key journals
to identify and cite articles, commentary and editorials, books reviews and
other content supporting our focus on vaccine ethics and policy. Journal
Watch is not intended to be exhaustive, but indicative of themes and
issues the Center is actively tracking. We selectively provide full text of
some editorial and comment articles that are specifically relevant to our
work. Successful access to some of the links provided may require
subscription or other access arrangement unique to the publisher. Our initial
scan list includes the journals below. If you would like to suggest other titles,
please write to David Curry at
david.r.curry@centerforvaccineethicsandpolicy.org

Clinical Infectious Diseases

1 August 2010 Volume 51, Number 3
http://www.journals.uchicago.edu/toc/cid/current
[Reviewed last week]

Emerging Infectious Diseases

Volume 16, Number 7–July 2010
http://www.cdc.gov/ncidod/EID/index.htm
[Reviewed earlier]

Human Vaccines
Volume 6, Issue 7 July 2010
http://www.landesbioscience.com/journals/vaccines/toc/volume/6/issue/7/
[Reviewed earlier]

JAMA
Vol. 304 No. 1, pp. 9-114, July 7, 2010
http://jama.ama-assn.org/current.dtl
[No relevant content]

Journal of Infectious Diseases

1 August 2010 Volume 202, Number 3
http://www.journals.uchicago.edu/toc/jid/current
[No relevant content]

The Lancet
Jul 10, 2010 Volume 376 Number 9735 Pages 69 - 140
http://www.thelancet.com/journals/lancet/issue/current
Editorial
G8–G20: standing at a crossroads
The Lancet
All eyes were on Canada, as first the G8 summit in Muskoka and then the
G20 summit in Toronto delivered their visions for the future. It is the first time
that the two groups have met so close in time and space, and provides an
opportunity to gauge what we can and should expect in terms of global
health governance from two very different groups.
A welcome cornerstone of the G8's final communiqué was the Muskoka
Initiative, which seeks to raise US$30 billion of new funds from G8 members
plus a group of non-G8 countries over the next 5 years to meet Millennium
Development Goals 4 and 5 on maternal, newborn, and child health.
However, with the 2011 G8 hosts, France, yet to commit to keeping maternal,
newborn, and child health on next year's agenda, and with the G8 still licking
its wounds after falling $15 billion short of its 2005 Gleneagles commitments,
there is ample opportunity for the G20 to seize the initiative on global health.
The G20 were willing to take up the slack from the G8 on that most
benighted of issues, financial regulation. On June 23, 2010, we published a
Viewpoint by Sudeep Chand and colleagues that posed the question: should
health be next? Judging by the final communiqué from Toronto, the G20 does
not yet have an answer. The communiqué mentions health only once, in the
context of strengthening social safety nets. However, it did commit to
forming a Working Group on Development tasked with devising a
development agenda to be outlined at the Seoul G20 summit in November.
Health has to be central to this agenda.
Brazil, Russia, India, and China signalled their intention to take a more
active role in world affairs in June last year, with Russian President Dmitry
Medvedev marking the first ever summit between the four countries by
saying they wanted to “create the conditions for a fairer world order”. These
countries have the political and economic capital to set the G20 agenda on
health, so let us hope they recognise that health security is not an optional
extra for a stable and prosperous world.
Viewpoint
Malaria in Africa: progress and prospects in the decade since the
Abuja Declaration
Robert W Snow, Kevin Marsh
Preview
Malaria is a global health problem but more than 70% of the total morbidity is
in Africa.1 10 years ago, heads of state from across Africa signed a
declaration in Abuja, Nigeria, to “halve the malaria mortality for Africa's
people by 2010”.2 This Viewpoint discusses how far we have come in this
effort, what we can expect for the future, and what our priorities should be.

The Lancet Infectious Disease

Jul 2010 Volume 10 Number 7 Pages 441 - 504
http://www.thelancet.com/journals/laninf/issue/current
[Reviewed earlier]
Nature
Volume 466 Number 7303 pp159-284 8 July 2010
http://www.nature.com/nature/current_issue.html
[No relevant content]

New England Journal of Medicine

Volume 363 — July 8, 2010 — Number 2
http://content.nejm.org/current.shtml
[No relevant content]

The Pediatric Infectious Disease Journal

July 2010 - Volume 29 - Issue 7 pp: A5-A6,585-684
http://journals.lww.com/pidj/pages/currenttoc.aspx
[Reviewed earlier: No relevant content]

Pediatrics
July 2010 / VOLUME 126 / ISSUE 1
http://pediatrics.aappublications.org/current.shtml
[Reviewed earlier: No relevant content]

PLoS Medicine
(Accessed 11 July 2010)
http://medicine.plosjournals.org/perlserv/?request=browse&issn=1549-
1676&method=pubdate&search_fulltext=1&order=online_date&row_start=1
&limit=10&document_count=1533&ct=1&SESSID=aac96924d41874935d8e1
c2a2501181c#results
[No relevant content]

Science
9 July 2010 Vol 329, Issue 5988, Pages 109-244
http://www.sciencemag.org/current.dtl
Special Report: HIV/AIDS
HIV/AIDS: Eastern Europe
Editorial:
AIDS Response at a Crossroads
Jessica Justman and Wafaa M. El-Sadr
Policy Forum
Gender Inequities Must Be Addressed in HIV Prevention
Rachel Jewkes
Building gender equity and reducing gender-based violence are vital
in the fight against AIDS.
Universal Access in the Fight Against HIV/AIDS
Françoise Girard, Nathan Ford, Julio Montaner, Pedro Cahn, and Elly Katabira.
Science Translational Medicine
7 July 2010 vol 2, issue 39
http://stm.sciencemag.org/content/current
[No relevant content]

Vaccine
Volume 28, Issue 30, Pages 4687-4858 (5 July 2010)
http://www.sciencedirect.com/science/journal/0264410X
Meeting Reports
Cholera vaccines: WHO position paper—Recommendations
WHO Publication
Abstract
This article presents the WHO recommendations on the use of cholera
vaccines excerpted from the recently published Cholera vaccines: WHO
position paper. This document replaces the WHO position paper on Cholera
vaccines published in the Weekly Epidemiological Record in April 2001.
Footnotes to this paper provide a limited number of core references; their
abstracts as well as a more comprehensive list of references may be found at
http://www.who.int/immunization/documents/positionpapers/en/index.html.
Grading tables which assess the quality of scientific evidence for key
conclusions are also available through this link and are referenced in the
position paper. In accordance with its mandate to provide guidance to
Member States on health policy matters, WHO issues a series of regularly
updated position papers on vaccines and combinations of vaccines against
diseases that have an international public health impact. These papers are
concerned primarily with the use of vaccines in large-scale immunization
programmes; they summarize essential background information on diseases
and vaccines, and conclude with WHO's current position on the use of
vaccines in the global context. This updated paper reflects the recent
recommendations of WHO's Strategic Advisory Group of Experts on
immunization (SAGE).
MALVAC 2009: Progress and Challenges in Development of Whole
Organism Malaria Vaccines for Endemic Countries, 3–4 June 2009,
Dakar, Senegal
M. Pinder, V.S. Moorthy, B.D. Akanmori, B. Genton, G.V. Brown
Abstract
Research and development into whole organism malaria vaccines is
progressing rapidly thanks to the major investments over recent years from
several funders, and the commitment and interest of many leading
researchers. Progress includes the discovery of potential new candidate
vaccines and the start of the first phase 1/2a clinical trial of the radiation
attenuated sporozoite approach for Plasmodium falciparum, under US Food
and Drug Administration regulatory oversight. A group of leading scientists,
clinical trialists and stakeholders, together with representatives of regulatory
authorities including some from African countries, met recently to document
the issues that will require detailed consideration to assess this promising
approach. Questions related to scale-up, quality, purity and consistency of a
manufacturing process using mosquitoes to generate a commercial product,
and demonstration of the stability of attenuated sporozoites will need further
work. Should a high level of efficacy be demonstrated in clinical challenge
studies, it will become a priority to agree in which populations and age
groups questions about strain-transcendence and duration of efficacy should
be answered, and how clinical development can progress with an approach
based on cryopreservation in liquid nitrogen.
Short Communications
Global production of seasonal and pandemic (H1N1) influenza
vaccines in 2009–2010 and comparison with previous estimates and
global action plan targets
Jeffrey Partridge, Marie Paule Kieny and the World Health Organization H1N1
influenza vaccine Task Force
Abstract
Immunization against influenza is considered among the most important
interventions in reducing the public health impact of seasonal epidemic and
pandemic influenza infections. However, there are marked differences across
countries with regards to production, supply and access to influenza
vaccines. A global action plan (GAP) to increase supply of pandemic influenza
vaccine was developed by the World Health Organization in May 2006 to
reduce the anticipated gap between potential vaccine demand and supply
during an influenza pandemic. To quantify the increase in global influenza
vaccine production capacity and actual production in response to the
influenza A(H1N1) 2009 pandemic, 3 years after the development of the GAP,
the WHO conducted a survey of vaccine producers from December 2009
through February 2010, and compared the results of this survey with results
from surveys conducted in 2006–2007 and May 2009.
Reviews
A summary of the post-licensure surveillance initiatives for
GARDASIL/SILGARD
Paolo Bonanni, Catherine Cohet, Susanne K. Kjaer, Nina B. Latham, Paul-Henri
Lambert, Keith Reisinger, Richard M. Haupt
Abstract
GARDASIL has been shown to reduce the incidence of pre-cancerous cervical,
vulvar, and vaginal lesions, and external genital warts causally related to
HPV6/11/16/18. Because of its expected public health benefit on reduction of
cervical cancer and other HPV-related diseases, this vaccine has been rapidly
implemented in the routine vaccination programs of several countries. It is
therefore essential to assess its impact and safety through post-licensure
surveillance programs. Here, we present a summary of 16 post-licensure
safety and impact studies across 20 countries. These studies address general
safety, including autoimmune disorders, long-term effectiveness, and type
replacement. A summary of the surveillance efforts of the Unites States
Centers for Disease Control and Prevention can be found in the
accompanying article by Markowitz et al.
Post-licensure monitoring of HPV vaccine in the United States
Lauri E. Markowitz, Susan Hariri, Elizabeth R. Unger, Mona Saraiya, S. Deblina
Datta, Eileen F. Dunne
Abstract
Post-licensure evaluation of vaccines plays an important role in monitoring
the progress of immunization programs, demonstrating population impact of
vaccines, and providing data for ongoing policy decisions. Two human
papillomovirus (HPV) vaccines are licensed and recommended for use in
females in the United States, a quadrivalent human HPV vaccine, licensed in
2006 and a bivalent vaccine HPV vaccine licensed in 2009. HPV vaccination is
recommended for females 11 or 12 years of age with catch-up vaccination
through age 26 years. Post-licensure monitoring of the HPV vaccine program
has included some of the same systems established for other vaccines, such
as those for vaccine safety and coverage monitoring. However, monitoring
HPV vaccine impact on infection and disease outcomes has required new
efforts. While there are well established cancer registries in the United
States, it will take decades before the impact of vaccine on cervical cancer is
observed. More proximal measures of vaccine impact include outcomes such
as prevalence of HPV vaccine types, incidence of cervical precancers and
genital warts. We review systems in place or being established for post-
licensure monitoring of HPV vaccine in the United States.
Regular Papers
Seasonal and Pandemic A (H1N1) 2009 influenza vaccination
coverage and attitudes among health-care workers in a Spanish
University Hospital
Silvia Vírseda, María Alejandra Restrepo, Elena Arranz, Purificación Magán-
Tapia, Mario Fernández-Ruiz, Agustín Gómez de la Cámara, José María
Aguado, Francisco López-Medrano
Abstract
Influenza vaccination coverage among health-care workers (HCWs) remains
the lowest compared with other priority groups for immunization. Little is
known about the acceptability and compliance with the pandemic (H1N1)
2009 influenza vaccine among HCWs during the current campaign. Between
23 December 2009 and 13 January 2010, once the workplace vaccination
program was over, we conducted a cross-sectional, questionnaire-based
survey at the University Hospital 12 de Octubre (Madrid, Spain). Five hundred
twenty-seven HCWs were asked about their influenza immunization history
during the 2009–2010 season, as well as the reasons for accepting or
declining either the seasonal or pandemic vaccines. Multiple logistic-
regression analysis was preformed to identify variables associated with
immunization acceptance. A total of 262 HCWs (49.7%) reported having
received the seasonal vaccine, while only 87 (16.5%) affirmed having
received the pandemic influenza (H1N1) 2009 vaccine. “Self-protection” and
“protection of the patient” were the most frequently adduced reasons for
acceptance of the pandemic vaccination, whereas the existence of “doubts
about vaccine efficacy” and “fear of adverse reactions” were the main
arguments for refusal. Simultaneous receipt of the seasonal vaccine (odds
ratio [OR]: 0.27; 95% confidence interval [95% CI]: 0.14–0.52) and being a
staff (OR: 0.08; 95% CI: 0.04–0.19) or a resident physician (OR: 0.16; 95% CI:
0.05–0.50) emerged as independent predictors for pandemic vaccine
acceptance, whereas self-reported membership of a priority group was
associated with refusal (OR: 5.98; 95% CI: 1.35–26.5). The pandemic (H1N1)
2009 influenza vaccination coverage among the HCWs in our institution was
very low (16.5%), suggesting the role of specific attitudinal barriers and
misconceptions about immunization in a global pandemic scenario.
The potential global market size and public health value of an HIV-1
vaccine in a complex global market
Carol A. Marzetta, Stephen S. Lee, Sandra J. Wrobel, Kanwarjit J. Singh, Nina
Russell, José Esparza
Abstract
An effective HIV vaccine will be essential for the control of the HIV pandemic.
This study evaluated the potential global market size and value of a
hypothetical HIV vaccine and considered clade diversity, disease burden,
partial prevention of acquisition, impact of a reduction in viral load resulting
in a decrease in transmission and delay to treatment, health care system
differences regarding access, and HIV screening and vaccination, across all
public and private markets. Vaccine product profiles varied from a vaccine
that would have no effect on preventing infection to a vaccine that would
effectively prevent infection and reduce viral load. High disease burden
countries (HDBC; HIV prevalence ≥1%) were assumed to routinely vaccinate
pre-sexually active adolescents (10 years old), whereas low disease burden
countries (LDBC; HIV prevalence rate <1%) were assumed to routinely
vaccinate higher risk populations only. At steady state, routine vaccination
demand for vaccines that would prevent infection only was 22–61 million
annual doses with a potential market value of $210 million to $2.7 billion,
depending on the vaccine product profile. If one-time catch-up campaigns
were included (11–14 years old for HDBC and higher risk groups for LDBC),
the additional cumulative 70–237 million doses were needed over a 10-year
period with a potential market value of $695 million to $13.4 billion,
depending on the vaccine product profile. Market size and value varied
across market segments with the majority of the value in high income
countries and the majority of the demand in low income countries. However,
the value of the potential market in low income countries is still significant
with up to $550 million annually for routine vaccination only and up to $1.7
billion for a one-time only catch-up campaign in 11–14 years old. In the most
detail to date, this study evaluated market size and value of a potential multi-
clade HIV vaccine, accounting for differences in disease burden, product
profile and health care complexities. These findings provide donors and
suppliers highly credible new data to consider in their continued efforts to
develop an HIV-1 vaccine to address the worldwide disease burden.